FDA Approves First New Drug in Decades for Alzheimer’s Treatment
Alzheimer’s disease is one of the most common brain disorders in adults over the age of 60 for which currently there is no cure.
Simply put, Alzheimer’s disease is a brain disorder that slowly damages learning, thinking, and memory- resulting in cognitive decline to the point of being unable to properly interpret reality or carry out daily tasks.
Scientists have developed a better understanding of the disease over the years, but they still do not fully understand exactly what causes it, which complicates the development of an effective treatment.
Current Treatment Options
Treating such a complex disease involves drug and environmental factors focused on maintaining mental function and slowing disease progression.
Currently, the FDA has only approved five prescription medicines:
Donepezil, Rivastigmine, Galantamine, Memantine, and a combination of Donepezil and Memantine.
These drugs are not effective for everyone, and different ones are recommended for individuals at different stages of disease progression.
A Memorable Milestone
As of June 2021, there is one more ray of hope to treat this soul-sucking disease- the FDA’s first approval of the first new Alzheimer’s drug since 2003!
After billions of dollars dedicated to research, there is finally a drug out there that works differently than the current standard (involving monoclonal antibodies instead of traditional neurotransmitter regulators).
Biogen Inc. is the maker of the new medication under the molecular name “Aducanumab” (branded as Aduhelm).
Unlike other orally administered drugs, Aduhelm is administered once a month, via IV drip and comes with a hefty price tag of $56,000 USD annually (approximately).
Aduhelm was approved via the FDA’s Accelerated Approval Program, with most members of the expert panel rejecting the treatment.
Despite this disagreement, the drug got accelerated approval anyway, which resulted in the resignation of some panel members in protest of the decision. This unusual approval process has sparked a congressional investigation into Biogen’s credibility and business practices.
The speedy approval also means that more research is necessary to verify any clinical benefit on outcomes such as the progression of cognitive decline or dementia. In phase three of clinical trials, Aducanumab showed conflicting evidence about the drug’s efficacy. Some trials found no benefit, while others saw a significant reduction in cognitive decline. Results of phase four clinical trials are expected by 2030, and if they cannot verify a significant clinical benefit, the FDA can withdraw the approval of the drug.
In fact, the FDA has already reversed its original recommendation of using Aduhelm to treat all Alzheimer’s patients and is now saying that only those in very early stages of the disease should receive the treatment.
With its price tag, this therapy is also becoming the focal point of the new American legislation that would allow the government to negotiate drug prices for national health insurance plans (if passed).
While it may seem surprising that such an expensive drug got approved; a drug that has not yet proven itself and cannot help all Alzheimer’s patients if proven effective, it still offers the promise of progress. With a rapidly aging population, this promise is enough to capture the attention of health ministries internationally, as seen with Health Canada’s recent acceptance to review the drug.
Current estimates list one in nine American seniors as affected by Alzheimer’s disease and there is no cure or universal formula with which to treat the illness.
Amid the controversy, it is important to remember that FDA approval does not mean “efficacious” or “cure”. The agency simply brings light to a safe drug that is ready for public distribution and evaluation. Right now there are questions about the FDA’s ties to drugmaker Biogen; coupled with the lack of scientific data proving the efficacy of Aducanumab, has led many people to question the drug’s approval, which really comes down to:
This breakthrough treatment brings hope to everyone affected by this unfortunate disease.
The buzz is simply related to the acknowledgment of innovation in a field that has remained stagnant for nearly two decades. Although more research is absolutely needed to make conclusions about Aduhelm, its approval presents a notable milestone in the community and is a nudge in the right direction for the future of Alzheimer’s disease treatment.
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Mayo Clinic, Staff. (2021, June 30). What new Alzheimer’s treatments are on the horizon? Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/in-depth/alzheimers-treatments/art-20047780.
The Economist Newspaper. (2021, July 15). Aduhelm may not cure Alzheimer’s, but it might help fix drug prices. The Economist. https://www.economist.com/united-states/2021/07/15/aduhelm-may-not-cure-alzheimers-but-it-might-help-fix-drug-prices.
U.S. Department of Health and Human Services. (n.d.). Alzheimer’s Disease Fact Sheet. National Institute on Aging. https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet.